Delay in Austin TX for Pluvicto

[Biobro]

It looks as if it is a problem country-wide. Just notified that spouse's 10 am Thursday appointment (4th infusion of 6) has been cancelled for inability to ship. Apparently they have some wiggle room and if it's only delayed a week or so, it won't knock him off the remaining schedule. Looks as if the US plant is still having trouble as this next dose is coming from Italy.

[Biobro]

Correction. Pluvicto has always been manufactured in Italy, but Novartis halted production there when the US manufacturing plant for Luthathera? had problems.

[Yank66]

We just had a two week delay for second dose. Official reason was bad batch. Remaining appointments were rescheduled six weeks apart.

[Biobro in reply to Yank66]

Thanks for the update. We're on tenterhooks because spouse is giving niece away at her wedding end of May and our current schedule fits perfectly! 2 week delay will be fine, 1 week not so much.😊

[Hh1976]

My father in Florida also had his treatment this week delayed. Really hoping it’s just a minor delay!

[john4803]

I just qualified for the Eclipse Trial in St. Louis, MO, & my study nurse wasn't sure where it is coming from but my first is scheduled for March 8th. She didn't say anything about delays. We'll see?

[Biobro]

Update:. Novartis still doesn't appear to be shipping. We've just been told that the most likely scenario is that last week's dose will be skipped completely and just added to the end of the current schedule. Apparently now no new patients are being started until the backlog of existing patients is cleared. No word if this means anything for clinical trials.

[Biobro]

Further update. It seems the actual problem is the FDA which has still not approved the NJ reactor for Pluvicto shipping. So, currently, NJ is shipping to everywhere in the word except the US and Italy is shipping to the US. So if there is a slight hiccup (not uncommon with radiotherapies apparently) in Italy the US can't eat! Apparently NJ is set to be approved for US shipping in June but that doesn't help anyone in the pipeline at the moment. The whole treatment schedule in the US was predicated on NJ coming on line way earlier and no one can figure out why the FDA is dragging its feet when every other country is just fine with them.

[Biobro]

Update again. They've just called and hubby is getting a new 6 week schedule from March 17th. So ultimately a 3 week delay. They're giving him the scheduled doses from a patient who dropped out.